Memantine 10mgml oral solution sugar free

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Memantine hydrochloride

थमां उपलब्ध:

Genus Pharmaceuticals Ltd

ए.टी.सी कोड:

N06DX01

INN (इंटरनेशनल नाम):

Memantine hydrochloride

डोज़:

10mg/1ml

फार्मास्यूटिकल फॉर्म:

Oral solution

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 04110000; GTIN: 5011309291315 5011309535716

सूचना पत्रक

MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
POINT SIZES USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
50ml/100ml
20065201
156 x 625mm flat (156 x 37mm folded)
4
02.02.2017
Memantine Hydrochloride 10mg/ml
Oral Solution
Yes
E
LHE
817651
13524
New product introduction
Helvetica
9pt,12pt, 22pt
Process Black
Keyline (non printing)
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE HYDROCHLORIDE 10MG/ML
ORAL SOLUTION
Memantine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Memantine Hydrochloride Oral Solution is and what it is used for
2.
What you need to know before you take Memantine Hydrochloride Oral
Solution
3.
How to take Memantine Hydrochloride Oral Solution
4.
Possible side effects
5.
How to store Memantine Hydrochloride Oral Solution
6.
Contents of the pack and other information
1. WHAT MEMANTINE HYDROCHLORIDE ORAL SOLUTION IS
AND WHAT IT IS USED FOR
Memantine Hydrochloride Oral Solution contains the active substance
memantine
hydrochloride.
WHAT IS MEMANTINE HYDROCHLORIDE ORAL SOLUTION USED FOR
Memantine Hydrochloride Oral Solution is used to treat patients with
moderate to severe
Alzheimer’s disease in adults.
HOW MEMANTINE HYDROCHLORIDE ORAL SOLUTION WORKS
Memantine Hydrochloride Oral Solution belongs to a group of medicines
known as anti-
dementia medicines.
Memory loss in Alzheimer’s disease is due to a disturbance of
message s

उत्पाद विशेषताएं

OBJECT 1
MEMANTINE HYDROCHLORIDE 10MG/ML ORAL
SOLUTION
Summary of Product Characteristics Updated 20-Nov-2017 | Genus
Pharmaceuticals
1. Name of the medicinal product
Memantine Hydrochloride 10mg/ml Oral Solution
2. Qualitative and quantitative composition
Pump: Each actuation of the pump (one downward pump) delivers 0.5 ml
of solution containing 5 mg of
memantine hydrochloride equivalent to 4.16 mg of memantine.
Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride
equivalent to 4.16 mg of memantine.
Each millilitre of solution contains 10mg of memantine hydrochloride.
Excipients with known effect:
Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5mg
of potassium, see section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution.
The solution is clear to colourless to light yellowish
4. Clinical particulars
4.1 Therapeutic indications
Treatment of patients with moderate to severe Alzheimer's disease.
4.2 Posology and method of administration
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of
Alzheimer's dementia. Therapy should only be started if a caregiver is
available who will regularly
monitor the intake of the medicinal product by the patient. Diagnosis
should be made according to current
guidelines. The tolerance and dosing of memantine should be reassessed
on a regular basis, preferably
within three months after start of treatment. Thereafter, the clinical
benefit of memantine and the patient's
tolerance of treatment should be reassessed on a regular basis
according to current clinical guidelines.
Maintenance treatment can be continued for as long as a therapeutic
benefit is favourable and the patient
tolerates treatment with memantine. Discontinuation of memantine
should be considered when evidence
of a therapeutic effect is no longer present or if the patient does
not tolerate treatment.
This medicinal product should be taken once daily at the same time
each day. The solution must not